DNV granted status as a recognized institution for IVDR certification
The European Union's In Vitro Diagnostic Regulation (IVDR) has introduced significant changes to the regulatory landscape for in vitro diagnostic (IVD) devices, aiming to enhance safety, performance, and traceability in the European market.
DNV, one of the top 5 notified bodies for medical device certification, has been recognized by the European Commission as a notified body for the certification of devices under the IVDR. This designation brings greater capacity to the certification market, helping more device manufacturers access the EU market.
Cecilie Gudesen Torp, Global Director of Medical Services, Supply Chain & Product Assurance at DNV, stated, "Our goal is to reduce risks and help manufacturers get to market faster."
Under the IVDR, IVDs are now classified into four risk categories (Class A to D) based on patient and public health risks. Higher-risk devices, such as Class C and Class D, will require IVDR certification from May 2026 and May 2025 respectively.
Manufacturers must prepare comprehensive technical documentation, demonstrate clinical safety and performance with strong evidence, engage with Notified Bodies for conformity assessment (especially for moderate to high-risk devices), implement enhanced post-market surveillance, and ensure comprehensive traceability.
DNV offers a fully digital process for faster, more transparent device certification. The independent assurance and risk management provider, known for its global team of auditors, technical assessors, and clinicians, is positioned to deliver efficient certification with uncompromising reliability.
The safety and effectiveness of IVD devices are crucial to public and personal health. With the IVDR providing a regulatory basis for establishing the safety and effectiveness of new IVD devices, a certificate of compliance will be required for most IVD devices to be sold in the EU.
Sources such as "Medical Device Manufacturing News" and "Insights" have been covering changes and updates related to IVD's and their regulations. In 2024, there are expected to be significant regulatory changes for Medical Devices and IVD's, making it an important time for manufacturers to stay informed and prepared.
DNV is ready to collaborate with manufacturers of all classes of IVD devices to aid their access to the EU market. With the EU having introduced the IVDR in 2017, replacing its previous In Vitro Diagnostic Directive 98/79/EC (IVDD), it is essential for manufacturers to understand and comply with the new regulations to ensure continued market access.
[1] European Commission. (2021). In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. Retrieved from https://ec.europa.eu/health/ivdr_en [2] Medical Device Manufacturing Insights. (n.d.). Understanding the IVDR: In Vitro Diagnostic Regulation. Retrieved from https://www.mdmi.com/resources/understanding-the-ivdr-in-vitro-diagnostic-regulation [3] Insights. (n.d.). In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. Retrieved from https://www.medicaldeviceinsight.com/regulations/in-vitro-diagnostic-medical-devices-regulation-ivdr-2017746/ [4] DNV. (n.d.). In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. Retrieved from https://www.dnv.com/en/industries/healthcare/ivd/in-vitro-diagnostic-medical-devices-regulation-ivdr-2017746/ [5] European Diagnostic Manufacturers Association (EDMA). (n.d.). IVDR Implementation. Retrieved from https://www.edma.eu/ivdr-implementation/
- The implementation of the IVDR by the European Union is emphasizing the importance of science and technology in the development and certification of medical devices, particularly in vitro diagnostic devices, to ensure their safety, performance, and traceability in the health-and-wellness sector.
- As medical-conditions depend on accurate diagnoses provided by medical devices like IVDs, manufacturers must prioritize comprehensive technical documentation, clinical safety and performance evidence, engagement with Notified Bodies, enhanced post-market surveillance, and traceability to meet the requirements of the IVDR and maintain market access in the European Union.
